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FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic
15 April 2021
PartnerBoston
Email scott.kaplan@hoganlovells.com
Phone +1 617 702 7732
Fax +1 617 371 1037
Practice groupGlobal Regulatory
Scott Kaplan helps pharmaceutical and biotechnology clients achieve and maintain compliance with complex Food and Drug Administration (FDA) requirements.
Drawing on his deep understanding of the FDA's civil and criminal enforcement, Scott prepares clients for FDA inspections and works with them to respond to FDA 483s, Warning Letters, import alerts, investigations by the Office of Criminal Investigations, and other FDA enforcement actions.
Scott provides experienced counsel on Current Good Manufacturing Practice regulations, data integrity issues, product labeling, and Drug Supply Chain Security Act implementation, among others.
Before joining Hogan Lovells, Scott served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. At the FDA, Scott helped the agency resolve seizures, injunctions, administrative detentions, and criminal prosecutions, in addition to serving as a Special Assistant U.S. Attorney. Scott also acted as counsel for compliance matters to the FDA's district offices. Prior to his tenure at the FDA, Scott clerked for the Hon. Helene N. White of the U.S. Court of Appeals for the Sixth Circuit.
Education
J.D., University of Pennsylvania Law School, magna cum laude, Order of the Coif, 2009
M. Bioethics, University of Pennsylvania Center for Bioethics, 2009
B.A., University of Pennsylvania, cum laude, 2002
Bar admissions and qualifications
Massachusetts
District of Columbia
Pennsylvania
Assist pharmaceutical and biotech companies respond to FDA enforcement actions related to GMP, GTP, and data-integrity issues.
Draft responses to FDA 483s, Warning Letters, and Import Alert notifications.
Perform GMP and GTP assessments as well as internal investigations for domestic and global pharmaceutical and biotech companies.
Advise companies on CMC-related issues in IND, NDA, and BLA submissions.
Represent companies in FDA Consent Decree negotiations and at Regulatory Meetings.
Assist companies with DSCSA compliance and supply chain management.
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